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# ModernaTX Hit with 483 Over GMPs
- URL: https://www.fdaweb.com/modernatx-hit-with-483-over-gmps/
- Published: 2024-01-05T12:00:00.000Z
- Updated: 2026-09-14T14:19:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156089

FDA has issued ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection of the firm’s Norwood, MA, facility documented GMP violations. For example, the [FDA-483 ](https://www.fda.gov/media/175123/download?ref=fdaweb.com)says equipment utilized for drug substance manufacturing is not cleaned properly prior to its usage. “Specifically, your firm does not ensure that the equipment used for drug substance manufacturing is appropriately cleaned prior to the manufacturing of mRNA-1273 drug substance,” it says. Other findings include:

- Cleaning validation studies of non-dedicated manufacturing equipment did not include challenges with actual conditions used in routine manufacturing processes.
- The firm failed to discard or move expired and hold/restricted materials to physical hold location per procedure to prevent the material being used beyond expiration date or restricted date. Expired materials were found utilized beyond their expiration date and restricted materials were utilized in mRNA drug substance production.
- The air handling systems are not adequately designed and controlled to assure appropriate air quality in the grade C cleanroom in which mRNA drug substance is manufactured. The positive pressure was not consistently maintained between the grade C cleanrooms and grade D airlocks.